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FDA 510(k) Application Details - K012012
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
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510(K) Number
K012012
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
H&C MEDICAL DEVICES SPA
VIA PISA 250
SESTO SAN GIOVANNI 20099 IT
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Contact
ATTILIO CASTELLI
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Regulation Number
870.2920
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Classification Product Code
DXH
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More FDA Info for this Product Code
Date Received
06/28/2001
Decision Date
01/17/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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